Organic Diet in Pregnancy and Risk Markers of Health Effects (The OrgDiet Project)

Not Applicable

Recruiting

• Conditions: Nutrition
• Interventions: Other: Conventional diet; Other: Organic diet

• Registration Number: NCT05269225
• Lead Sponsor: Per Ole Iversen, MD

Brief Summary

The OrgDiet project is a two-armed (1:1), open, intention-to-treat randomized controlled trial. The aim is to examine effects of consumption of organic foods (intervention group) vs. conventional foods (control group) during pregnancy in both mother and child. About 100 participants will be included and the participants will be followed until the children are two years old. Both groups will also be recommended to eat according to the dietary guidelines of the Directory of Health in Norway.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-07
• Study Start: 2022-05-02
• Status Verified: 2024-12
• Primary Completion: 2025-01-31
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Nulli- or multipara pregnant in first trimester

Exclusion Criteria

• Consuming an organic diet regularly
• Using medication regularly that might interfere with study adherence or - outcomes
• Diagnosed with a chronic disorder or cancer
• Having a food allergy or intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional diet	Conventional diet	Consuming conventional food throughout the whole pregnancy.
Organic diet	Organic diet	Consuming organic food from the start of 2nd trimester and until gestational week 37.

Primary Outcome Measures

Name	Time	Method
Maternal urinary excretion level of dialkylphosphates	2.5 years	The difference in maternal urinary excretion level of these pesticides at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby.

Secondary Outcome Measures

Name	Time	Method
Abundance and species-types of gut microbiota (e.g. staphylococci and enterobacter) sampled from stool samples	2.5 years	The difference in microbiota species-types and abundance (using 16S rRNA amplicon sequencing) in stool samples between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby.
Child body length	2 years	The difference in child body length (cm) between the intervention group and the control group, measured at baseline (birth), and at several occasions until 2 years after the birth of the baby.
Child body weight	2 years	The difference in child body weight (kg) between the intervention group and the control group, measured at baseline (birth), and at several occasions until 2 years after the birth of the baby.
Blood concentration HbA1c	2.5 years	The difference in blood concentration of HbA1c at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby.
DNA methylation patterns in leucocytes as a marker of altered epigenetic programming	2.5 years	DNA methylation will be investigated on DNA isolated from leukocytes. Degree of DNA methylation will be analyzed at a genome-wide scale using Illumina Infinium EPIC bead chip array (or similar methods, depending on the cost-benefit consideration at the time). The DNA methylation data will be normalized, and presented as beta-values ranging from 0-1. The outcome measure in the study is intra-individual DNA methylation changes during the study-period, measured as changes in the beta-value, between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby.
Blood concentration of cholesterol	2.5 years	The difference in blood concentration of cholesterol at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby.
Child urinary excretion level of dialkylphosphates	2 years	The difference in child urinary excretion level of dialkylphosphates between the intervention group and the control group, measured at several occasions until 2 years after the birth of the baby.
Blood concentration CRP	2.5 years	The difference in blood concentration of CRP at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby.

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Norway